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Second Amendment on Phase I Trial NO7VEG 'Assessment of a Next Generation Indwelling Provox Voice Rehabilitation System (Vega)': Vega Siri Addendum.


Phase 1/Phase 2
N/A
N/A
Not Enrolling
Both
Total Laryngectomy

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Trial Information

Second Amendment on Phase I Trial NO7VEG 'Assessment of a Next Generation Indwelling Provox Voice Rehabilitation System (Vega)': Vega Siri Addendum.


Inclusion Criteria:



- Total laryngectomy

- Use Provox ActiValve

Exclusion Criteria:

- Current problems with TE puncture

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Short-term Feasibility Provox Vega 22.5 French

Outcome Description:

Number of participants in whom the voice prosthesis was considered feasible in the short-term with regards to clinical and technical aspects as judged by patient and investigator.

Outcome Time Frame:

3 weeks

Safety Issue:

No

Principal Investigator

Frans JM Hilgers, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Netherlands Cancer Institute

Authority:

Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:

UD778

NCT ID:

NCT00743262

Start Date:

April 2008

Completion Date:

April 2009

Related Keywords:

  • Total Laryngectomy
  • laryngectomy
  • larynx cancer

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